- Assay Kit Now Available for Use Without a Prescription -
- Approved for Immediate Use by CLIA-certified Laboratories -
- Positions Assay Kit to Support Reopening (Return-to-School/Return-to-Work) Strategies -
- Increases Testing Throughput via Addition of New Robotic Extraction Platform -
- Immediate Deployment in Applied DNA’s CLIA-certified Clinical Lab -
Applied DNA Sciences, Inc. (NASDAQ: APDN) (Applied DNA or the “Company”), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company’s Linea™ COVID-19 Assay Kit (the “Assay Kit”) a re-issued Emergency Use Authorization (EUA) that expands the Assay Kit’s intended use to include serial screening of asymptomatic individuals. The expanded intended use allows for the serial testing of individuals with or without symptoms, eliminates the prescription requirement, and returns results to individuals. With the recent receipt of CLIA certification by its Applied DNA Clinical Labs, LLC (ADCL) subsidiary, the expanded intended use enables the Company to now offer recurring testing strategies with individual result reporting without a prescription to support the safer reopening of schools, workplaces, nursing homes and skilled nursing facilities, and other places where people gather regularly in numbers. The Assay Kit with its expanded intended use is also available for immediate purchase by CLIA-certified laboratories nationally.
“The expanded intended use for our Assay Kit supports our systematic approach to expanding the addressable market for our COVID-19 testing services and Assay Kit that is aligned with COVID-19 ‘normalization’ strategies and funding sources aimed at reopening the economy,” said Dr. James A. Hayward, president and CEO, Applied DNA. “The ability to return results to the individual and the elimination of the prescription requirement, we believe, substantially differentiates ADCL’s services in the testing market and elevates the value of our Assay Kit to clinical laboratories that can now bring to bear our high sensitivity PCR-based test – still the gold standard for COVID-19 diagnostics – to help prevent people with asymptomatic infections from turning into unsuspecting super-spreaders. We are further characterized by the ability of our Assay Kit to discriminate some variants. We believe that a rigorous serial testing program is the most effective way to confirm current COVID-19 status as part of any reopening strategy.
“As access to vaccines expands and certain COVID-19-related restrictions are eased, the confluence of vaccinated, under-vaccinated, vaccine ineligible, or otherwise immune-compromised populations, particularly in such mixed settings as skilled nursing facilities where staff and patients interact, makes asymptomatic serial testing more relevant to at-risk populations. Asymptomatic serial testing, together with a greater testing throughput afforded to us and those CLIA-certified laboratories that purchase our Assay kits that now are authorized for additional robotic automation, makes our Assay Kit a compelling solution to support the nation’s effort to reopen and limit wild-type and variant viral spread.”
Under the re-issued EUA, serial testing of asymptomatic individuals for SARS-CoV-2 requires individuals to be tested weekly and with no more than seven days (168 hours) between serially collected specimens. The re-issued EUA also further expands the addressable market for the screening or diagnostic use of the Assay Kit by authorizing the use of the KingFisher™ Flex Purification System, a high-throughput robotic nucleic acid extraction system in wide use by CLIA-certified laboratories nationally. With the addition of the KingFisher system to the EUA, ADCL will have a daily testing capacity of several thousand COVID-19 samples.
Dr. Hayward concluded, “The expanded intended use is also complementary to safeCircleTM, our pooled surveillance COVID-19 testing platform. Together with CLIA certification, we can now offer clients the choice between conventional physician-ordered diagnostic testing, non-pooled individual screening testing, and pooled surveillance testing, thereby allowing us to provide a range of COVID-19 testing programs that can be tailored to meet the unique testing requirements of a diverse range of clients.”
About Applied DNA Sciences
Applied DNA is commercializing LinearDNA™, its proprietary, large-scale polymerase chain reaction (“PCR”)-based manufacturing platform that allows for the large-scale production of specific DNA sequences.
The LinearDNA platform has utility in the nucleic acid-based in vitro diagnostics and preclinical nucleic acid-based drug development and manufacturing market. The platform is used to manufacture DNA for customers as components of in vitro diagnostic tests and for preclinical nucleic acid-based drug development in the fields of adoptive cell therapies (CAR T and TCR therapies), DNA vaccines (anti-viral and cancer), RNA therapies, clustered regularly interspaced short palindromic repeats (CRISPR) based therapies, and gene therapies. Applied DNA has also established a COVID-19 diagnostic and testing offering that is in the early stages of commercialization and is grounded in the Company’s deep expertise in DNA.
The LinearDNA platform also has non-biologic applications, such as supply chain security, anti-counterfeiting and anti-theft technology. Key end-markets include textiles, pharmaceuticals and nutraceuticals, and cannabis, among others.
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The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW.’
Applied DNA is a member of the Russell Microcap® Index.
About the Linea™ COVID-19 Assay Kit
The LineaTM COVID-19 Assay Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens including anterior nasal swabs, self-collected at a healthcare location or collected by a healthcare worker, and nasopharyngeal and oropharyngeal swabs, mid-turbinate nasal swabs, nasopharyngeal washes/aspirates or nasal aspirates, and bronchoalveolar lavage (BAL) specimens collected by a healthcare worker from individuals who are suspected of COVID-19 by their healthcare provider (HCP). The test is also intended for use with anterior nasal swab specimens that are self-collected in the presence of an HCP from individuals without symptoms or other reasons to suspect COVID-19 when tested at least weekly and with no more than 168 hours between serially collected specimens.
The scope of the Linea™ COVID-19 Assay Kit EUA, as amended, is expressly limited to use consistent with the Instructions for Use by authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated or until the EUA’s prior termination or revocation. The diagnostic kit has not been FDA cleared or approved, and the EUA’s limited authorization is only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The Company is offering surveillance testing in compliance with current CDC, FDA, and CMS guidances. The use of saliva and pooled sampling for surveillance testing, which has been internally validated by the Company in compliance with current surveillance testing guidances, is not included in the Company’s EUA authorization for the Linea™ COVID-19 Assay Kit.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies, and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to its history of net losses, limited financial resources, limited market acceptance, the possibility that the assay kit could become obsolete or have its utility diminished, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partner’s diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration (U.S. FDA) or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies and/or the New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, changes in guidances promulgated by the CDC, U.S. FDA and/or CMS relating to COVID-19 surveillance and diagnostic testing, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 17, 2020, and Form 10-Q filed on February 11, 2021 and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
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